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    DRUG CLASS:

    CD22-targeted antibody-drug conjugate

    Related drugs:
    12d
    Retrospective analysis of inotuzumab-associated hepatotoxicity in adult patients with B-cell acute lymphoblastic leukemia: Expanding the Spectrum of calicheamicin syndrome. (PubMed, J Oncol Pharm Pract)
    Median time to hepatotoxicity improvement after InO discontinuation was 18 days, and no patients progressed to SOS.ConclusionCalicheamicin Syndrome represents a reproducible and reversible hepatotoxic entity distinct from SOS, characterized by InO exposure, transaminitis, thrombocytopenia, abnormal hepatic imaging, and HSC on pathology. Early recognition may facilitate monitoring and prevent progression to severe hepatic injury.
    Retrospective data • Journal
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    CD22 (CD22 Molecule)
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    Besponsa (inotuzumab ozogamicin)
    15d
    Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma (clinicaltrials.gov)
    P2, N=68, Active, not recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: May 2028 --> May 2029 | Trial primary completion date: May 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
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    CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule)
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    CD22 positive
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    clonoSEQ
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    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine • dexamethasone injection
    16d
    ALLight: Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=83, Recruiting, AstraZeneca
    Trial initiation date
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    CD22 (CD22 Molecule)
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    CD22 positive
    23d
    Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) (clinicaltrials.gov)
    P2, N=25, Suspended, University of Chicago | Recruiting --> Suspended
    Trial suspension
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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    dasatinib • Iclusig (ponatinib) • Besponsa (inotuzumab ozogamicin) • vincristine
    25d
    A041703: Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=84, Recruiting, National Cancer Institute (NCI) | N=64 --> 84
    Enrollment change
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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    CD22 positive
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    Iclusig (ponatinib) • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    1m
    International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) (clinicaltrials.gov)
    P3, N=750, Not yet recruiting, Charite University, Berlin, Germany
    New P3 trial
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    CD22 (CD22 Molecule)
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    CD19 positive • CD22 positive
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    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    1m
    Ph-Negative Acute Lymphoblastic Leukemia in the Older Adults: Biology, Therapeutic Strategies and Unmet Needs. (PubMed, Eur J Haematol)
    In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL.
    Review • Journal • IO biomarker
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    TP53 (Tumor protein P53)
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    TP53 mutation
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    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    2ms
    Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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    Besponsa (inotuzumab ozogamicin) • Nailike (olverembatinib)
    2ms
    A041501: Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=310, Suspended, Alliance for Clinical Trials in Oncology | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
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    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule) • ITGB1 (Integrin Subunit Beta 1)
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    CD20 positive • CD22 positive
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    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine
    2ms
    Inotuzumab Ozogamicin in Clinical Practice: an Overview of Efficacy, Safety, and Real-World Applications. (PubMed, Curr Hematol Malig Rep)
    Despite recent advancements, patients with B-cell ALL tend to have poorer outcomes, especially in the adult population. Future research and larger scale prospective studies are indicated to evaluate the efficacy of InO in different lines of therapy.
    Review • Journal • Real-world evidence
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    CD22 (CD22 Molecule)
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    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    2ms
    ALLight D9891C00001: A trial to learn how safe AZD4512 is and how it works in the bodies of people with B-cell acute lymphoblastic leukemia (B-ALL) (2025-522372-93-00)
    P1/2, N=13, Recruiting, AstraZeneca AB
    New P1/2 trial
    2ms
    D9890C00001: A trial to learn how safe AZD4512 is with and without other cancer drugs and how it works in the bodies of people with B-cell non-Hodgkin lymphoma (B-NHL) (2025-522371-29-00)
    P1/2, N=12, Recruiting, AstraZeneca AB
    New P1/2 trial